Apparatus and methods for monitoring objects in a surgical field

ABSTRACT

A system and method for performing a package status check are provided, including a scanner for use in a surgical field and having an antenna for emitting a radio frequency detection field, the scanner including control circuitry configured to determine a predetermined quantity of sponges corresponding to a complete pack of sponges; count a number of sponges associated with the pack with the scanner prior to use of the sponges in a surgical field; and issue an alert when a number of counted sponges does not match the predetermined quantity corresponding to the complete pack. The system and method may include the control circuitry configured to determine whether a sponge has been re-scanned or is unknown by comparing detected information with previously detected information prior.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/904,805, filed Jun. 18, 2020, and entitled “Apparatus and Methods forMonitoring Objects in a Surgical Field,” which is a continuation of U.S.patent application Ser. No. 15/957,131, filed Apr. 19, 2018, andentitled “Apparatus and Methods for Monitoring Objects in a SurgicalField,” which is a continuation of U.S. patent application Ser. No.15/498,931, filed Apr. 27, 2017, and entitled “Apparatus and Methods forMonitoring Objects in a Surgical Field,” which is a continuation of U.S.patent application Ser. No. 15/051,257, filed Feb. 23, 2016, andentitled “Methods for Monitoring Objects in a Surgical Field,” which isa continuation of U.S. patent application Ser. No. 14/629,106, filedFeb. 23, 2015, and entitled “Methods for Monitoring Objects in aSurgical Field,” which is a divisional of U.S. patent application Ser.No. 13/927,467, filed Jun. 26, 2013, and entitled “Apparatus and Methodsfor Monitoring Objects in a Surgical Field,” which This application is acontinuation of U.S. patent application Ser. No. 13/597,817, filed Aug.29, 2012, and entitled “Apparatus and Methods for Monitoring Objects ina Surgical Field,” which is a continuation of U.S. patent applicationSer. No. 13/041,996, filed Mar. 7, 2011, and entitled “Apparatus andMethods for Monitoring Objects in a Surgical Field,” which is adivisional of U.S. application Ser. No. 11/901,094, filed Sep. 13, 2007,and entitled “Apparatus and Methods for Monitoring Objects in a SurgicalField,” which claims the benefit of and priority to U.S. ProvisionalApplication No. 60/844,175, filed Sep. 13, 2006, the entirety of each ofwhich is herein incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

The present invention is directed toward apparatus and methods formonitoring the entry of objects into a surgical field and the exittherefrom and for monitoring a surgical patient to determine if any suchobjects are within the patient.

It is of critical importance that the entry of objects into a surgicalfield and into a surgical site, as well, as their removal be verycarefully reconciled so as to avoid inadvertent retention of an objectwithin a patient. Counting objects entering and exiting a surgical fieldis a conventional operating room procedure. Such practices greatlyreduce the risk of an object being inadvertently retained within thepatient. Such procedures typically involve the manual counting ofobjects entering and exiting the surgical field, as well as the visualexamination of the surgical site. It is critical that such procedures becompleted before the surgical site is closed. In the event that thesurgical site needs to be closed with minimum delay, it is necessary tofinish the verification that there is no object retained in the patientas quickly as possible. It is therefore desirable to provide effectiveand timely means and methods of monitoring objects entering and exitinga surgical field with a high degree of accuracy and with minimum effortfrom medical personnel.

SUMMARY OF THE INVENTION

Apparatus and methods are provided for monitoring objects havingidentifiers in a surgical field. Such objects may include surgical aidssuch as surgical sponges, surgical instruments such as scalpels andneedles, medical supplies and other tools utilized by medical personnelin a surgical field such as writing instruments. Additional examplesinclude items in the surgical field which may or may not be used in asurgical procedure. Other objects may include, for example, items wornby medical personnel or surgical patients such as watches, glasses,dentures, hearing aids, surgical scrubs caps, gloves and identity cards.

An identifier on an object to be monitored may be a radio frequency (RF)tag or a microchip that utilizes any other suitable technology toidentify objects. Alternatively, an object may be equipped tospontaneously emit electromagnetic waves containing identificationinformation, which may be read by antennas. A bar code may also beattached to an object in order to identify it. An object may also beidentified using pattern recognition technology, whereby a visual imageof the object is obtained, and control circuitry algorithms are utilizedto identify the object from its image. Any other suitable identifier orcombination of identifiers may also be used.

The apparatus may include an object entry detection zone and an objectexit detection zone. The object entry detection zone may be adapted toreceive new objects dispensed from a housing prior to introduction intoa surgical field while the object exit detection zone may be adapted toreceive used objects discarded into said housing after exit from saidsurgical field.

One or more scanners may be operatively associated with the object entrydetection zone and the object exit detection zone, respectively. Saidscanners may each contain one or more antennas which may detect anindividual object or a plurality of objects substantiallysimultaneously, for example, by emitting a detection field within thedetection zones. The antennas may also detect the objects after theyhave entered a recess, for example, by emitting detection fields intothe recess. A control circuitry may be operatively associated with thescanners for controlling the operation of the scanners.

Various approaches to controlling the signals emitted from the antennasare provided. In one embodiment, all of the antennas are powered, andthe control circuitry controls the tuning and detuning of the antennassuch that when one antenna is tuned, the others are detuned. Anotherembodiment involves powering one antenna tuned to a specific resonantfrequency during a period of operation while the other antennas areunpowered. In yet another embodiment, control is effected by switchingboth the powering and tuning of the antennas.

In a further embodiment, one antenna emits a signal out-of-phase withrespect to the signals from at least one other antenna. A furtherembodiment utilizes the mechanical movement of one antenna with respectto other antennas.

In another embodiment, the invention further provides a plurality ofantennas preferably disposed within a housing or mat so as to underlieat least a portion of the patient undergoing a surgical procedure foremitting detection fields upwardly and for detecting objects within thepatient or otherwise in or around the surgical site. A furtherrefinement of this embodiment involves an upper antenna which may be ina handheld device helping to direct the detection field. In oneembodiment, the upper antenna may provide a loop surrounding thesurgical site.

Various approaches to protecting identifiers from deterioration and datacorruption are provided. In certain embodiments, identifiers may bewrapped or encapsulated in protective casing.

Various approaches to preventing electromagnetic coupling betweenidentifiers are also provided. In one embodiment, identifiers may bepositioned at strategic locations on objects that increases thedistances between the identifiers, and objects may be packaged in aspecific order. In another embodiment, objects may be wrapped orencapsulated in protective casing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a form of system of one embodimentof the invention.

FIG. 2 shows a package of objects of one embodiment of the invention.

FIGS. 3 and 4 are perspective views taken from opposite sides of a unitillustrating a system containing both object entry and object exitunits.

FIG. 5 is a schematic illustration of a form of system of one embodimentof the invention.

FIG. 6 shows a visual display of one embodiment of the invention.

FIG. 7 is an elevational, cross-sectional illustration of one side of aunit of the type shown in FIGS. 3 and 4.

FIG. 8 is an elevational, cross-sectional illustration of the oppositeside of the unit shown in FIG. 7.

FIG. 9 is a perspective view of an intake system usable in theembodiment of FIGS. 1 through 8 showing the entry detection unit.

FIG. 10 is a perspective view of the entry detection unit of the systemof FIGS. 1 through 8 taken generally from the rear thereof.

FIG. 11 is a perspective view partially broken away of an exit detectionunit of the embodiment of FIGS. 1 through 8.

FIG. 12 is another perspective view of the exit detection unit of FIGS.1 through 8.

FIGS. 13a and 13b are respectively a schematic elevational illustrationand a plan of single structure which functions as both an entrydetection zone and an exit detection zone.

FIG. 14 is an illustration of another embodiment of the inventionwherein a plurality of antennas is positioned under the patient.

FIG. 15 is a schematic illustration of the positioning within a housingof a plurality of antennas for the embodiment of FIG. 17.

FIGS. 16a and 16b show a mat of one embodiment of the invention.

FIG. 17 shows a top plan view of another embodiment wherein an antennais provided on an adhesively backed member which may be secured directlyto the patient.

FIG. 18 is a side elevational view of the embodiment shown in FIG. 17.

FIG. 19 shows a schematic front elevational view of a modified form ofthe object detecting apparatus of the present invention.

FIG. 20 is a cross-sectional illustration of the object detectingapparatus of FIG. 19 taken through 16-16.

FIG. 21 is a schematic illustration showing the object receiver and itsrelative movement with respect to a pair of fixed antennas.

FIG. 22 is a cross-sectional illustration taken through FIG. 19 at18-18.

FIG. 23 shows a modified version of the object detecting apparatus ofFIGS. 19 through 22.

FIG. 24 is a perspective view of a form of scanner having the capabilityfor effecting movement of an antenna with respect to theobject-receiving portion of the scanner.

FIG. 25 is a fragmentary detailed view of a portion of the scanner ofFIG. 24.

FIG. 26 illustrates another embodiment of the invention providing forestablishing movement between an antenna and the object-receiving recessof the scanner.

FIG. 27 is a perspective view showing a pair of antennas which may besubject to relative movement with respect to the scannerobject-receiving recess.

FIG. 28 has an exploded view of six generally square closed-loopantennas and associated tuning circuits which, when assembled, mayfunction in a scanner of the present invention.

FIG. 29 is a perspective view of an assembly of antennas created fromthe individual antennas shown in FIG. 28.

FIG. 30 is a partially schematic illustration of a single antenna withtwo opposing loops connected by a bridge along with its tuning circuit.

FIG. 31 shows a pair of looped antennas and their associated tuningcircuits placed in relative position which enables them to create arotating field.

FIG. 32 is a perspective view of a pair of spaced, loop antennascombined with a pair of antennas configured as in FIG. 31.

FIG. 33 is a perspective view of a group of antennas.

FIG. 34 is a perspective view of a form of system of one embodiment ofthe invention.

FIG. 35 is a front elevational view of the system illustrated in FIG.34.

FIG. 36 is a left-side elevational view of the system shown in FIG. 34.

FIG. 37 is a right-side elevational view of the system shown in FIG. 34.

FIG. 38 is a rear elevational view of the system shown in FIG. 34.

FIG. 39 is a top plan view of the system shown in FIG. 34.

FIG. 40 is a bottom plan view of the system shown in FIG. 34.

FIG. 41 shows a memory structure of an RF tag in one embodiment of theinvention.

FIG. 42 shows a protective outer wrapping or covering of a package ofobjects in one embodiment of the invention.

FIG. 43 shows adjacent objects utilizing a placement of tags of oneembodiment of the invention.

FIG. 44 shows adjacent objects utilizing a placement of tags of oneembodiment of the invention.

FIG. 45 shows an object with a padded pocket of one embodiment of theinvention.

FIGS. 46a and 46b show a top view and a side view of an encapsulatingcovering of one embodiment of the invention.

FIGS. 47a and 47b show an encapsulating covering with a bump feature ofone embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

As employed herein, the term “patient” means a member of the animalkingdom including humans.

As employed herein, “surgical site” means the portion of the patient'sbody where the surgery will be or has been performed and adjacentportions of the surgical table or bed supporting the patient.

As employed herein, “surgical field” means the sterile environment whichincludes the patient, equipment and personnel which will be or might beemployed during a surgical procedure.

As employed herein, the term “non-optical” refers to a method or systemthat does not require the use of line-of-sight visible light.

As employed herein, the term “object in a surgical field” or “object”refers to objects found in the sterile, environment which includes thepatient, equipment and personnel which will be or might be employedduring a surgical procedure.

Referring to FIG. 1, there is shown a plurality of objects 2, 4, 6 and8, each equipped with an identifier (not shown) which may distinguisheach object from the others in the group. Objects 2, 4, 6 and 8 may becontained in individual packages. If objects 2, 4, 6 and 8 havepackages, identifiers may be placed either directly on the object or onthe outside of the object's package. For example, FIG. 2 shows packaging202 which can contain any suitable number of objects. An identifier 204is placed on packaging 202 in order to identify packaging 202. Theidentifier may include a numerical identifier, an alphabeticalidentifier or an alpha-numeric identifier. Furthermore, certainadditional information may be provided on the identifier such as thespecific type of object, the manufacturer, the plant where it wasmanufactured, the package identifier of a package which contains aplurality of individually identified objects, the total number ofobjects in a package and any other desired information.

If desired, the user may be able to differentiate between objectsbelonging to different packages. Different packages, each containing aplurality of objects, may each contain a package identifier thatcontains information on the objects within the packages, such as thenumber of objects in the package. The objects may also each containtheir own unique identifier as well as a package identifier that uniqueto a package but is common among all items in a given package. Theobjects may also contain a quantity identifier that indicates thecorrect quantity of items that should be present in the package. Thesystem may be set up to initially read a package identifier and quantityidentifier from one or more of the tags in a package to determine thepackage identity and the number of objects that are supposed to be inthe package. The system may then count the number of objects with thesame package identifier by detecting the unique identifier of eachobject in the package. The system may compare the number of objects thatare supposed to be in the package with the number of objects that are inthe package in order to verify that that package is complete, beforeusing the package in a surgical field. If the system detects that apackage is incomplete, the user may be alerted that the package may beincomplete, or that identifiers on one or more objects in the packagemay be malfunctioning.

Control circuitry 30 may be programmed to take the package identifierand quantity data from an individual identifier in the exit detectionzone and use this to add all of the remaining items not yet scanned bythe exit detection zone from the same package to the list of itemsdetected in the entry detection zone. Although the software does not yethave the unique identifiers for these items not yet scanned, it createsa placeholder for them. This provides a user who forgot to scan in apackage with a more accurate representation of the surgical inventorythan the user would otherwise have had. By using package identifier aswell as quantity data, the software may prevent confusion in the casethat another partial pack is discarded before being scanned in.

If desired, the user may be able to differentiate between objectsbelonging to different packages. Different packages, each containing aplurality of objects, may each contain a package identifier thatcontains information on the objects within the packages, such as thenumber of objects in the package. The objects may also each containtheir own unique identifier. The system may be set up to initially reada package identifier to detect the number of objects that are supposedto be in the package. The system may then count the number of objectswith the same package identifier by detecting the unique identifier ofeach object in the package. The system may compare the number of objectsthat are supposed to be in the package with the number of objects thatare in the package in order to verify that that package is complete,before using the package in a surgical field. If the system detects thata package is incomplete, the user may be alerted that the package may beincomplete, or that identifiers on one or more objects in the packagemay be malfunctioning.

In one embodiment, when these objects enter a detection field, theidentifiers may emit responsive data thereby enabling the system, in themanner to be described hereinafter, to identify the specific objectwhich is in the field. The identifier may be any suitable identifiersuch as one with an integrated circuit and an antenna (e.g., a copperwire loop or printed circuit antenna). This may enable the system toidentify the specific type of object, to count the objects and toconfirm the presence of the object on an individual basis orsubstantially simultaneously for a plurality of objects.

The identifiers on the objects may also be programmed as they are read.They may be assigned a unique number from a predetermined list ofnumbers or from a random number generator. Utilizing a random numbergenerator achieves the same goal as utilizing a predetermined list ofnumbers. The manufacturer may also provide information regarding thedate and location of manufacturing as well as other identifyinginformation.

The identifiers on an object may also be programmed with informationabout the object's treatment history, such as, for example,sterilization of the object. For example, when an object is sterilized,its identifier may be programmed with information such as the date ofsterilization, the particular process used for sterilization, the dateof expiration of the sterility of the object and other desirableinformation. When an object is received in the object entry detectionzone 16, the system may check the date of expiration of the sterility.The user may be alerted if the sterility of the object has expired.Additionally, the system may decode encrypted information, stored on theidentifier, that identifies the particular sterilization process used onthat item, and may issue a warning or take other appropriate action ifthe object was not sterilized using a validated sterilization process.

The objects 2, 4, 6 and 8 may be received in the object entry detectionzone 16 sequentially or simultaneously. A plurality of antennas 24, 26and 28 may be operatively associated with (e.g., coupled to) the objectentry detection zone 16 to detect and read data from the identifiers.The antennas 24, 26 and 28 may establish a field within recess 20, andmay thereby facilitate determining the identity of each object enteringthe object entry detection zone 16. The data received by the antennas24, 26 and 28 may be delivered to control circuitry 30 which may recorddata regarding each object entering the object entry detection zone 16.The control circuitry 30 may also function as a controller to provideenergizing power to antennas 24, 26 and 28 and to control operationthereof in respect of various parameters and in the proper sequence topermit substantially simultaneous identification of a plurality ofobjects. A visual display unit 34 may be controlled by control circuitry30 and may provide a visual display with whatever information is desiredregarding each object 2, 4, 6 and 8 being introduced into the objectentry detection zone 16.

While the system may employ a plurality of antennas at the entrydetection zone 16 and the exit detection zone 40, such as the threeantennas 24, 26 and 28 shown in FIG. 1, the system may alternatively beemployed with a single antenna in the entry detection zone 16 or exitdetection zone 40, if desired. Identifier orientation with respect tothe antenna may then become more important. In this latter case, it maybe preferable to place the identifier of the object flat against theantenna. The manufacturer could create the identifiers with a consistentdesired known flat configuration to facilitate uniform size, shape andpositioning within a single or multiple packages of objects intended foruse in a single antenna system.

In operation, the objects 2, 4, 6 and 8 may be delivered, eithermanually or by another means, from the object entry detection zone 16into the surgical field 36. At that point, the control circuitry mayhave a record of each specific object that has entered into the surgicalfield 36. The user may detect one object at a time or a plurality ofobjects simultaneously. If the user desires to detect only one object ata time, the system may produce an error message if more than one objectis detected simultaneously.

Objects that are employed within the surgical field may be introducedinto the object exit detection zone 40 after use. The object exitdetection zone 40 may be coupled with a plurality of antennas 42, 44 and46. The antennas 42, 44 and 46 may generate a detection field within theobject exit detection zone 40 such that specific identification of eachidentifier on each object is provided. This may be accomplished in amanner to be described hereinafter for a plurality of objectssimultaneously. The data received may be delivered to control circuitry30 for comparison and storage therein with the output being shown on thevisual display 34. The visual display 34 may be provided with controlswhich may permit simultaneous display of object entry data and objectexit data as well as other desired information.

A single object or package of objects may be introduced into the objectentry zone 16, which may be provided with a single antenna or aplurality of antennas, such as antennas 24, 26 and 28. It may not benecessary to remove the individual objects from the package in order tohave the identifier of each object read. Two or more antennas may beused so that the orientation of the objects and, therefore, theorientation of the identifiers need not be controlled with respect tothe antennas. Using two or more antennas that may be scanned usingnon-optical means may also ensure a reading regardless of the depths ofobjects within the body of a patient. For example, each antenna may bepositioned at a different location along the body of the patient,thereby ensuring that a wide reading range is covered.

If desired, the object entry detection zone 16, rather than being aseparate structure, may be provided at the discharge end of an objectdispenser such as a sponge dispenser. In this embodiment, the system mayfunction as with the object entry zone 16 and may have withdrawal of theobject from the storage container serving as the act triggeringdetection.

If desired, the control circuitry 30 may be so structured as to permit auser to insert a request for a predetermined number of objects to bedispensed automatically from the storage container under control of thecontrol circuitry. The control circuitry may then store information fromthe identifiers on the objects regarding the act of dispensing and thespecific unique identifying information of the object being dispensed,as well as the count of dispensed objects.

The control circuitry 30 may also store other information about anobject such as its weight. In one embodiment, entry detection zone 16and exit detection zone 40 in FIG. 1 may be equipped with scales (notshown) for weighing objects such as surgical sponges. Upon entry intothe object entry detection zone 16, an object may be weighed, and itsinitial dry weight recorded by control circuitry 30. After being usedand upon entry into the object exit detection zone 40, the object may beweighed again, and its final weight recorded by control circuitry 30.Control circuitry 30 may compare the initial and final weights in orderto determine the total amount of blood or fluid that has been removedfrom the patient onto said object.

The function and data integrity of identifiers may be verified at theobject entry and exit detection zones. In one embodiment, when an objectenters the entry detection zone or the exit detection zone, controlcircuitry 30 be may used to compare the data read from the object'sidentifier with data pre-programmed into control circuitry 30. If thedata on the object's identifier does not match the data pre-programmedinto control circuitry 30, the user may be alerted. This may ensure thatall identifiers are functional. In another embodiment, control circuitry30 may be programmed to detect identifiers that are malfunctioning, suchas identifiers that may have become damaged during shipping or a packageidentifier that may have been manufactured with an incorrect number ofobjects. The user may be alerted about the occurrence of suchmalfunctioning identifiers. This may for example prevent the incorrectcounting of objects or other errors.

Where multiple antennas such as antennas 24, 26, 28 or 42, 44, 46cooperate with respect to a particular detection zone 16 or 40, it maybe preferred that they function as individuals with the controlcircuitry 30 controlling the sequence and manner in which each antennawill function. For example, the control circuitry 30 may be structuredto tune and detune the antennas within a group (24, 26, 28) (42, 44, 46)such that during a period of operation of one said antenna within agroup, it is tuned to a specific resonant frequency, the remainingantennas of the group are detuned with respect to that frequency. Powermay be supplied to only the antenna being tuned.

In another embodiment, one antenna may be powered to a specific resonantfrequency during a period when the others are unpowered. In an alternateembodiment, one antenna may be caused to emit a signal out-of-phase withrespect to the others. Mechanical movement of the antennas sequentiallymay be employed. The timing of each individual antenna's activation mayvary, but may be on the order of about 250 to 1000 milliseconds per fullcycle, for example. The antennas of each group (24, 26, 28) or (42, 44,46) may be cycled in this manner so that each antenna will be subjectedto each isolated parameter. Any suitable orientation of antennas, or acombination of orientation of antennas, may additionally be used.

Referring to FIGS. 3 and 4, there are shown two perspective views of acart 60 which, in the form shown, may contain both the object entrydetection zone 62 and the object exit detection zone 64. Entry detectionzone 62 may have an enclosure 70 defining an outwardly open recess 72within which objects bearing identifiers may be introduced, eitherindividually or in the original package. Alternatively, entry detectionzone 62 may not have an enclosure. FIG. 5 shows one embodiment where asingle antenna 504 (not shown) is located within a horizontally orientedentry zone 502. As shown in FIG. 5, the device has an LCD screen that isat a slight angle to vertical and a horizontally oriented entry zone 502in which the entry zone antenna 504 lies at a slight angle tohorizontal. It may be desirable to use a flat panel instead of an openrecess when, for example, objects that may not fit into an open recessneed to be introduced into the entry detection zone (e.g. a matcontaining antennas, identifiers or both as discussed in connection withFIGS. 16a and 16b ). Referring back to FIGS. 3 and 4, if a plurality ofobjects is within a single package, each object may have an identifier.The cart 60 may be positioned within the surgical field or closelyadjacent thereto. Prior to introducing objects into the surgical site,the control circuitry, which may be within housing 80, in a manner to bedescribed hereinafter, may monitor the unique identification of eachobject entering a detection zone and store that data. This mayfacilitate identification of the specific object, (i.e., its type andother characteristics) and also the count of objects entering thesurgical field. Housing 80 may also contain a first visual display 82for displaying data regarding objects processed through object entrydetection zone 16 and object exit detection zone 64. A second visualdisplay 84 may display the same data, but may permit viewing from theother side. The housing 80 may be supported on a post 81 which may besecured to the upper surface 83 of object entry detection zone 62.Visual displays 82 and 84 may, for example, be LCD displays or any othersuitable displays.

Visual displays 82 and 84 may be unattached to housing 80. In anotherembodiment, visual displays 82 and 84 may be integrated into one visualdisplay and may be a device separate from housing 80. For example, thevisual display may be a wall-mounted display that communicates withcontrol circuitry 30 through a wired or wireless connection. The visualdisplay may be an LCD display or any other suitable display. FIG. 6shows visual display 34 which is a wall-mounted display.

Objects that are withdrawn from the surgical site may be introduced intoupwardly open recess 86 of the object exit detection zone 64 and may beidentified and counted. Data regarding the objects may be displayed onscreens 82 and 84 of housing 80. The objects which pass through exitdetection zone 64 may then be received in a collection container (notshown) which may be removed from cart 60 to dispose of the objects in asafe manner. The collection container may be a plastic bag of suitablesize and strength which may be removable and secured within upwardlyopen recess 86 (FIG. 3).

The displays 84, 82 and 34 in FIGS. 3, 4 and 6, respectively, mayvisually display the data regarding objects. For example, display 34 inFIG. 6 may show a chart having a first column 602 listing the objects ina surgical field, a second column 604 listing the objects entering thesurgical field, a third column 606 listing the objects exiting thesurgical field and a fourth column 610 providing a checkmark or “X” markindicating whether or not the same number of a given object has enteredand left the surgical field. In an alternative embodiment, the firstcolumn may list a specific object identity with the second columnproviding a checkmark, “X” mark or other indication showing that anobject has entered the surgical field and a third column providing spacefor a checkmark, “X” mark or other indication showing that an object hasexited the surgical field. Various other means of providing the desiredinformation regarding the monitored objects entering and exiting thesurgical field may be visually displayed on displays 84, 82 or 34 withor without desired additional information.

Referring to FIGS. 3 and 4, the object entry detection zone 62 andobject exit detection zone 64 may each be structured to monitor aplurality of objects passing into respective zones 62 and 64substantially simultaneously regardless of the orientation of theobjects. The antennas may be designed, positioned and operated in such amanner to permit such simultaneous monitoring. Further, as the scannersmay be of a non-optical type, the presence of blood, other body fluidsor body tissues on the object or identifier will not interfere withobtaining accurate readings. The cart 60 in the form shown may havewheels 90, 92, 94 and 98 at the corners as well as manually-operatedbrakes 100, 101, each associated with one wheel 90 and 94. In the formshown, a pair of handles 102 and 104 are provided for facilitatingmovement of the cart 60. Such handles may be optionally used inconjunction with any embodiment of the invention.

The body of the cart housing may be made of any suitable materials thatare structured to have the adequate strength to support the equipment,avoid interference with the functioning of the equipment and be capableof maintaining the cleanliness required in a surgical field. Suitablematerials that may be used include resinous plastics, non-ferrous metalsand medium-density fiberboard (MDF), to name a few.

Referring to the cross-sectional illustrations of cart 60 of FIGS. 3 and4 in FIGS. 7 and 8, there is shown the object entry detection zone 72with the overlying visual display housing 80. Referring to FIGS. 7through 10, a plurality of antenna tuning circuits 110, 112 and 114which may be respectively operatively associated with antennas 122, 124and 126, may be powered and controlled by control circuitry 30 ofFIG. 1. A tuning circuit, such as tuning circuits 110, 112 and 114, maybe in the form of a circuit board and may function to alter tuning todetermine the resonant frequency of a specific antenna with which it isoperatively associated. The antennas 122, 124 and 126 in the form shownmay be made of rigid copper tubing and therefore be self-supporting.Other self-supporting or non-self-supporting materials with additionalsupports provided may alternatively be used. Each antenna 122, 124, 126may be a closed loop which surrounds the recess 72 within which theobjects are scanned.

The antennas 122, 124 and 126 need not be coplanar with each other andmay rather be at an angle to each other. The tuning circuits 110, 112and 114, while each operatively associated with an antenna 122, 124 and126, respectively, may not need to have any particular orientation withrespect to the other tuning circuits 122, 124 and 126. The antennas 122,124 and 126 may be controlled by control circuitry 30 through tuningcircuits 110, 112 and 114.

The control circuitry 30, in the form shown, may be disposed withinvisual display unit 80. The control circuitry 30 may control andcoordinate the detection fields emitted by each successive antenna. Asstated above, the control circuitry 30 may be structured to tune anddetune the antennas such that during the period of operation, oneantenna 122, 124 or 126 is tuned, while the other antennas are detuned.This may create a progression of detection fields and, with the datareceived back from the identifiers secured to each of the objects, maypermit the control circuitry 30 to receive data from a plurality ofobjects substantially simultaneously (e.g., on the order of tens tohundreds of milliseconds or more, although typically not longer thanseveral seconds) and regardless of object orientation. The tuned antennain this embodiment may be tuned to a specific frequency with theremaining antennas being detuned as to that frequency. Each antenna maysequentially be tuned while the others are detuned.

An alternate approach to cycling the operation of the respectiveantennas 122, 124 and 126 may be to deliver power to the antennas suchthat one antenna, such as 122, is powered to a specific resonantfrequency during a period of operation and the remaining antennas 124and 126 are unpowered with respect to that frequency with successivestages resulting in each antenna 122, 124 and 126 being tuned to thedesired resonant frequency, while the others are detuned.

In one embodiment, only a single antenna of the group of the pluralityof antennas may be powered at a time and only that antenna may be tunedat that time with the rest being unpowered and detuned. After that,another antenna may be powered and tuned with the rest being unpoweredand detuned until the complete cycle involving simultaneously poweringand tuning an individual antenna is accomplished. An unpowered antenna,while still tuned, can nevertheless pick up ambient energy and act as ifit were powered. One can, as indicated above, cycle just the power, butthis may be less preferred in certain cases due to the possibility ofunwanted interactions among antennas. One could also have all of theantennas powered simultaneously and cycle the tuning, but this may beless preferred in certain cases due to the increased consumption ofenergy.

In another embodiment, one antenna, such as antenna 122, may emit asignal out-of-phase with respect to the signals from the other antennas124 and 126 with the cycle of operation involving sequential emission ofa signal out-of-phase by each individual antenna.

Yet another embodiment may involve the mechanical movement of a firstantenna while one or more of the other antennas are stationary. Thismovement may be translational movement, rotational movement or any othersuitable type of movement, or a combination thereof.

Referring to FIGS. 11 and 12, with reference to the object exitdetection zone 64 as shown in FIGS. 3 and 4, the structure has a housing120 which may define an upwardly open recess 122 into which objectsemerging from the surgical site may be introduced. Within the housing120 (not shown) may be a receiving container for safely receiving andstoring the used objects, which have passed through object exitdetection zone 64, until safe disposal can be arranged. This containermay be a suitably sized plastic bag having the desired strength. Thehousing 120, which, in the form shown tapers slightly downwardly, mayhave a closed bottom. Support frame 130 may serve as a support for theobject exit detection zone 64.

Also shown in FIGS. 11 and 12 are antenna tuning circuits 136, 138 and140, which may each be operatively associated respectively with a loopantenna 142, 144 and 146. The antennas may be of the same material andgeneral configuration and relative orientation as the entry detectionzone antennas. Loop antennas 142, 144 and 146 may be positioned at anangle to each other. This arrangement may facilitate the ability of thesystem to monitor and uniquely identify each object through itsidentifier, counting the exiting objects and identifying the type,regardless of relative orientation of the objects within recess 122 asthe objects move downwardly through. The same general concepts describedabove in respect to the control of the antennas shown in FIGS. 9 and 10may be employed in this context.

Referring to FIGS. 13a and 13b , another embodiment of the inventionwill be considered. In this embodiment, the construction of the devicemay be similar to the object exit detection zone shown and described inconnection with FIGS. 11 and 12. In this embodiment, the tuning circuits136, 138 and 140 may be operatively associated with their respectiveantennas 142, 144 and 146. Housing 120 may have an overlying cover 121and may define a recess 150 which may have a divider wall 152 dividingthe recess into compartments 154 and 156. Except for the dividing wall152 dividing the recess 150 into compartments 154 and 156, thestructural and functional arrangement may be similar or substantiallyidentical to that shown and described in connection with FIGS. 11 and12. In the present embodiment, however, a first compartment 154 mayfunction as the object entry zone and the second compartment 156 mayfunction as the object exit zone which would have a suitable containersuch as an appropriate bag (not shown) to collect the used and/ordiscarded objects.

Control circuitry 30 may be programmed in a manner known to thoseskilled in the art so as to determine whether it is functioning as anobject entry zone or an object exit zone at a given time, to either scanin the objects entering or to scan out the objects exiting the surgicalfield. In one embodiment, a control circuitry 30 may rely on contextualdata to determine if it is detecting a particular object or group ofobjects within a single package for the first time after controlcircuitry 30 is started up (e.g., scanning the objects into the surgicalfield) or the second time (e.g., scanning them out of the surgicalfield). An alternate approach may be to establish a flag in the objectidentifiers upon scanning them in order to confirm that unflaggedobjects are new and need to be scanned in. Upon exiting, the controlcircuitry 30 may determine the existence of previously flagged objectidentifiers which are being counted out. Control circuitry 30 may alsobe used to avoid re-using already-used objects. Control circuitry 30 mayestablish a flag with a certain value in the identifier of an object thefirst time it is scanned in the entry detection zone. If an identifierwith a flag of that value is scanned, control circuitry 30 may warn theuser that a used object is being be re-used, e.g., by a visual orauditory alert. Control circuitry 30 may also prevent the user fromscanning subsequent objects when an identifier that has been flagged isscanned. The user may be equipped to over-ride control circuitry 30 whena warning is received and continue scanning. For example, the user maybe provided with a pre-determined code that the user can enter intocontrol circuitry 30 to continue scanning. The user may also be given anOverride card which may be pre-programmed using RFID. If necessary, theuser may scan the Override card at the appropriate scanner in order tocontinue scanning an object or to end the current scan and start thenext one.

In another embodiment, control circuitry 30 may be adapted to maintainobject counts and identities even when objects are introduced into theexit detection zone before they are introduced into the entry detectionzone. For example, control circuitry 30 may be programmed to compare thelist of identifiers detected in the exit detection zone with the list ofidentifiers detected in the entry detection zone. If an identifier isfound on the list of identifiers detected in the exit detection zone butnot on the list of identifiers detected in the entry detection zone, theidentifier may be added to the list of identifiers detected in the entrydetection zone. Alternatively, the user may be allowed to programcontrol circuitry 30 to scan in objects in the exit detection zonewithout scanning them in the entry detection zone. This may bedesirable, for example, in the case of an emergency when the user doesnot have time to scan objects in the entry detection zone before usingthem. The system may also be set up to maintain a count of the objectsin a given package that have been scanned in the exit detection zonewithout being scanned in the entry detection zone, and to notify theuser of the number of remaining objects in the package.

In yet another embodiment, control circuitry 30 may establish differenttypes of flags in the object identifiers. For example, if it is requiredthat an object that has been used in a surgical procedure be sanitizedand reused, the control circuitry may establish a new type of flag inthe object's identifier each time the object is scanned at the entrydetection zone. The control circuitry may also store information aboutthe object and the times it re-entered the entry detection zone. After asurgical procedure, the control circuitry may be consulted to getinformation about the frequency and timing of use of certain objects.

Among the additional features which may advantageously be providedthrough the control circuitry 30 are various alarm and warning systems.In one embodiment, the control circuitry may be programmed to comparethe count and identity of objects processed by the entry scanner withobjects processed by the exit scanner. The control circuitry may confirmthat all objects entering said surgical field have been removed from thesurgical field and may initiate an alarm in the event that, at the endof a surgical procedure, comparison of the data from the entry scannerwith the data from the exit scanner indicates that not all the objectsentering the surgical field have exited the surgical field. Controlcircuitry 30 may also stop the scanning of subsequent objects ifcomparison of the data from the entry scanner with the data from theexit scanner indicates that not all the objects entering the surgicalfield have exited the surgical field. The user may be equipped toover-ride control circuitry 30 when a warning is received. For example,the user may be provided with a pre-determined code that the user canenter into control circuitry 30 to continue scanning. The user may alsobe given an Override card which may be pre-programmed using RFID. Ifnecessary, the user may scan the Override card at the appropriatescanner in order to continue scanning.

In another embodiment, the device may warn the user to change the bag orcontainer within the object exit detection zone 64 when the container isgetting full of used objects. It may also provide a warning if a packageof objects does not contain the proper number or kind of objects or ifan identifier is not functioning properly on the scan in the objectentry detection zone 62. In another embodiment, the bag or container mayinclude an identifier. Control circuitry 30 may warn the user and/orstop functioning if the exit detection zone antennas do not detect theidentifier of the bag. This ensures safer use of the device. Moreover,the control circuitry may be programmed to issue an alarm if there is aneffort to scan the same object or package of objects into the objectinput inspection zone twice. In a manner known to those skilled in theart, the alarm may take the form of an audio alert or alarm, a visualalert or alarm, any other suitable alert or alarm or a combinationthereof. The control circuitry may for example provide the visual alarmon the display screen.

Referring to FIGS. 14 and 15, there is shown a surgical table which mayhave a suitable base 180, a support column 182 disposed in underlyingsupporting relationship with a horizontally extending patient support184 over which a series of cushioned patient supports 190, 192 and 194may be provided. During surgery, the supports 190, 192 and 194 may becovered by an appropriate sterile drape with the patient placed inposition overlying the same. The support 184 may have a transverserecess within which may be inserted a housing 200 of the presentinvention containing a single antenna or an array of antennas structuredto generate an upwardly directed detection field. A number of antennas,such as for example, between 2 and 6 or more, may be employed, asdesired.

As shown in the schematic drawing of FIG. 15, the housing 200 in theform shown may contain a plurality of antennas 210, 212, 214, 216, 218and 220, each of which may be connected to electrical connector 222 byrespective wires 230, 232, 234, 236, 238 and 240. The wires 230, 232,234, 236, 238 and 240 may in turn emerge from the housing 200 as shownin FIGS. 14 and 15 to an electrically conductive wire 246. Wire 246 maybe connected to control circuitry 250 which may serve the multipurposeof supplying power to and controlling operation of the antennas 210,212, 214, 216, 218 and 220, as well as receiving data returned from theidentifiers on objects in the surgical site or adjacent thereto. Thecontrol circuitry 250 may also control the time and content of thedetection fields being generated by the antennas by providing power toeach one in sequence, by tuning and detuning the same to a specificdesired resonant frequency or by controlling the signals emitted by thesame to create an out-of-phase relationship. In the form shown, thehousing 200 may be inserted completely into the horizontal support 184.The housing 200 may then underlie the surgical site so as to generate adetection field within the patient and surgical site to obtain data onwhether any object is in the patient or has been left in the patient ata time approaching closing the patient after surgery. The system mayalso be employed, if desired, to determine what objects are in a patientor, more generally, are in the surgical field, and at what locationimmediately prior to, during and after a surgical procedure.Additionally, information about the amount of blood and fluid loss maybe obtained, as previously discussed.

A support post 260 may have a floor-supported base 247 which may serveto support the control circuitry 250 and a visual display unit 264 maybe positioned at a higher elevation than the control circuitry 250 andmay be secured to support post 260 by clamp 261. This may provide readyvisual access to the visual display window 266. Suitable control buttonssuch as 265, 267, 268 and 269 may be provided on the visual display unit264 to provide a display of the desired information.

Referring to FIG. 14, in addition to or instead of the underlying lowerarray of antennas 210, 212, 214, 216, 218 and 220 contained withinhousing 236, the invention may include the use of a handheld antenna 270which may be contained within a handheld wand 272. The handheld wand 272may be electrically energized by wire 278 and may also serve tocommunicate data to and from the control circuitry 250. In thealternative, the antenna 270 may be unpowered. If desired, a pluralityof antennas may be employed in the handheld wand 272. This overlyinghandheld wand 272 may be moved around the patient and/or the surgicalfield so as to cooperate with the underlying antenna-containing housing200 in order to define a section field.

In one embodiment, lower antennas 210, 212, 214, 216, 218 and 220 may beelectromagnetically coupled with handheld antenna 270 in order toincrease the reading range of the lower antennas. Lower antennas 210,212, 214, 216, 218 and 220 may also vary the direction of the detectionfield created by handheld antenna 270 as it is moved across the patientin a manner such that the resulting magnetic field contains vectorcomponents of more varied direction than if handheld antenna 270 wereused alone. This may increase the likelihood of activating and readingidentifiers positioned in arbitrary orientations within a patient'sbody.

In another embodiment, lower antennas 210, 212, 214, 216, 218 and 220may be embedded or otherwise attached to a mat that may be placed on topof the surgical table and under the patient. It may then take the formof a mat, which may be reusable or disposable. Having a disposable matmay be desirable for example, in a surgical procedure where any itemplaced under a patient may become soiled. The mat may be made of one ormore different materials and may be of different shapes and/ordimensions. In one embodiment, the mat may be a modified surgical tabledrape. The mat may also contain identifiers which may be detected byhandheld antenna 270. Identifiers of the mat may also be inspected bythe entry detection zone, the exit detection zone, or both (e.g. byfolding the mat so that it fits within the zone or by using a flat entryor exit detection zone, as illustrated in FIG. 5). A plurality ofidentifiers may be encoded with specific information indicating theirlocation relative to the other identifiers in the mat. The identifiersmay be positioned at various locations in the mat and control circuitry30 may instruct the user to scan the identifiers in the mat in aspecific order. This may ensure that the user scans the entire body ofthe patient when scanning with handheld wand 272. This may in turnensure an accurate detection of all the objects within the patient'sbody. For example, FIG. 16a shows a mat according to one embodiment ofthe invention. Mat 600 may have antennas, such as antennas 602, 606 and608 embedded in it which may be used to read information fromidentifiers on objects in the surgical field. Antennas 602, 606 and 608may each include a loop of circuit trace made of any suitable conductivematerial and a tuning circuit (e.g. tuning circuits 616, 618 and 620respectively). Mat 600 may also have one or more identifiers, such asidentifiers 604, 610, 612 and 614 which may be detected by handheldantenna 270 in order to ensure that the entire surgical site is scanned.Mat 600 may include perforation 622, along which mat 600 may be tornafter a surgical procedure for ease of disposal. Mat 600 may also be inthe form of a continuous roll, allowing the user to pull and tear off asection along perforation 622 as desired. As shown in FIG. 16b , visualdisplay 34 may instruct the user to scan identifiers 604, 610, 612 and614 in mat 600 in a specific order. Arrows a, b and c may show the orderin which identifiers 604, 610, 612 and 614 may be scanned. In thisexample, the order of scanning may be identifier 604, identifier 610,identifier 612 and lastly, identifier 614. Visual display 34 may displayinformation relating to objects (e.g. the number and identity of theobjects it detects) as well as information regarding handheld antenna270 (e.g. whether or not handheld antenna 270 is within reading range ofmat 600). Control circuitry 30 (FIG. 1) may, for example, determinewhether handheld antenna 270 is in range by determining whether handheldantenna 270 can read identifiers 604, 610 612 and 614 in mat 600. Ifhandheld antenna 270 is not within reading range of identifiers 604,610, 612 and 614 in mat 600, a warning may be issued using anyappropriate method, and the user may be asked to adjust the location ofthe handheld antenna to achieve proper reading range.

The identifiers in the mat may also be used to ensure that a new mat isused for each surgical procedure. In one embodiment, the mat may bescanned at the beginning of a surgical procedure with the antennas inobject entry detection zone 16 or with handheld antenna 270. A flag maybe established in each identifier in the mat that is scanned in. Forexample, each identifier that is scanned in at the beginning of asurgical procedure may have a flag set to “true.” Control circuitry 30may then be set up to detect any identifier that has a flag set to“true” and to alert the user that the mat being scanned may be used.This may prevent a mat from being used in more than one surgery. Controlcircuitry 30 may also be set up to prevent subsequent scanning ofidentifiers when it detects an identifier that has a flag indicatingthat it has already been scanned (e.g. at the beginning of a surgicalprocedure). The user may be equipped to over-ride control circuitry 30when control circuitry 30 prevents the scanning of identifiers. Forexample, the user may be provided with a pre-determined code that theuser can enter into control circuitry 30 to continue scanning. The usermay also be given an Override card which may be pre-programmed usingRFID. If necessary, the user may scan the Override card at theappropriate scanner in order to continue scanning.

The handheld antenna 270, which may be disposed within the handheld wand272, may be employed to act as an entry or exit antenna therebyproviding added data from objects that are scanned in and out of thesurgical field with an additional reading in respect of the surgicalsite. There are several ways in which this may be accomplished. Thehandheld antenna 270 may operate in a default mode such that it scansobjects which are being taken out of the surgical site. It may also beemployed in a contextual manner so that the first time it sees aspecific identifier on a specific object, it is regarded as entering thesurgical site while the second time it sees it, it is regarded asexiting the surgical site. There may also be an additional user controlin the form of a switch, such as a toggle switch (not shown), on thehandle of the handheld antenna 272 for the user to determine whetheritems are being scanned in or out.

In one embodiment, handheld wand 272 may not be attached to support post260 by wire 278 and may powered for example by using batteries. In thisembodiment, handheld wand 272 may be moved over a range of distanceswithin the surgical field. Handheld antenna 270 may as a result have awider reading range and may be able to produce a detection field with agreater range of directionality. Handheld wand 272 may also contain anidentifier (not shown). Lower antennas 210, 212, 214, 216, 218 and 220may be used to detect the identifier in handheld wand 272 when handheldwand 272 is at different locations from the surgical site. This mayensure that the reading range of handheld wand 272 is confirmed beforeit is used to detect identifiers that may be in the body of a patient.The visual display unit 264 may also be employed to present data fromthe handheld wand 272.

If desired, the antenna containing housing 200 may be permanently orremoveably secured to the surgical table or the antennas could otherwisebe permanently or removeably secured to the table.

If desired, the handheld unit may also be employed with otherembodiments in the invention, including but not limited to thosedescribed in the context of FIGS. 1-12.

FIGS. 17 and 18 show another embodiment wherein an antenna assembly 300may have an upper layer 302 on which is secured an antenna 304. Antenna304, in the form shown, may be a rectangular loop having a pair of freeends 306 and 308. Free ends 306 and 308 may be secured to a connector310 which may have an electrically conductive element 312 which may bestructured to transmit data to and from the control circuitry (notshown) and, if the antenna 304 is to be powered, to energize the same.In the form shown, the antenna 304 may be of metal tubularconfiguration. The antenna 304 may be secured to an underlying layer 320which may have an undersurface provided with a pressure-sensitiveadhesive 322. An opening 324 may permit the antenna to be secured aroundthe site of the surgical incision (not shown). It will be appreciatedthat the opening 324 and antenna size and configuration may be providedin a number of sizes and shapes in order to accommodate differentsurgical procedures and incision sizes.

Antenna 304 may be powered, or it may be unpowered and have the pad 302powered. If the antenna 304 is unpowered, the antenna may be connectedto the control circuitry (not shown in this view) and report back itsdata or may be completely unconnected and simply act as a guide todirect, define or extend the range of field from other antennas. In thisform, the antenna may be provided as a disposable item. In a furtherembodiment, the construction of FIGS. 17 and 18 may combine theabove-described antenna with an electrocautery grounding pad in order topermit an electrocautery machine to function.

Referring now to FIGS. 19 through 22, a further embodiment of theinvention will be considered. In this embodiment, in the form shown, apair of closed-loop antennas 330 and 332 may be made of a tubularelectrically conductive material such as copper, and may be at an angleto each other. In the form shown, vertically oriented antenna 330 may bedisposed about 40% to about 60% of the distance D between the frontportion of generally horizontal antenna 332 and the rear portionthereof. A rotatable object receiver 336 may have a rear wall 340, apair of spaced walls 342 and 344 and a base wall 346 which may cooperateto define an object-receiving recess 356. As shown in FIG. 19, therotatable object receiver 336 may have a support rod 352 which may haveopposed ends secured within housing 360 with a first end 362 beingreceived within housing wall 364 and a second end 366 being receivedwithin housing wall 370. The housing may have an upper wall 372, a lowerwall 374 which may have an opening 376 to permit objects to be withdrawntherethrough and a rear wall 378.

Elongated rod 364 may either be fixedly secured to the housing 360 withthe object receiver 336 being rotatable with respect thereto or, in thealternative, the object receiver 336 may be fixedly secured to elongatedrod 364 which may have its ends 362 and 366 rotatably secured withinhousing walls 364 and 370.

In FIG. 22 reference number 336 shows the object receiver 336 in theforward position while reference number 33 e shows the object receiver336 in the rearward position. The object receiver 336 may rotate in thedirection indicated by two-headed arrow A. As shown in FIG. 20, the basewall 374 of housing 360 has an opening 376 through which objects may bedischarged into a container 380 when the receiver is rotated rearwardly.It will be preferred that the angle .alpha. embraced by the forwardmostposition of object receiver 336 and rearwardmost position 336.sup.1 besuch that in the forwardmost position, one or more objects may beintroduced easily into the object receiver 336, while in the rearmostposition, the object or objects will readily drop under the influence ofgravity into underlying container 380 (FIG. 22). The angle .alpha.between the forwardmost position and rearwardmost position may be about40 .degree. to about 90 .degree.

In FIG. 22, there is shown a number of objects 382, 384, 386, 388, 390,392, 394 and 396 which have been delivered into receiver 336 anddeposited into the container 380. In this form, the rotatable receiver336 has been used in the object exit detection zone. When used in theexit mode, it will be appreciated that the housing 360 and the receiver336, as well as the antennas contained therein, may be positioned overthe desired collection container 380 which may have different sizes andshapes, if desired. This embodiment may also be employed in the objectentry zone with delivery of the object to an individual who would removeit from the object receiver 336.

The embodiment of FIGS. 19 through 22 may be employed with a pluralityof objects being processed simultaneously. The system, in respect ofcontrol circuitry interaction, could function in the above-describedmanner.

Referring to FIG. 26, a refinement of the embodiment of FIGS. 19 through22 is shown. In this embodiment, a pair of side antennas 390 and 392 maybe disposed on opposite sides of antennas 330 and 332 oriented at anangle to each other. This may facilitate reading object identifiers in athird dimension. These antennas 390 and 392 are oriented generallyparallel with respect to each other. While in the form shown, theantennas 390 and 392 are of generally circular configuration, otherconfigurations may be employed, if desired.

Referring to FIGS. 24 and 25, there is shown a scanner housing 400 whichmay define an upwardly open object-receiving recess 402. A closed-loopantenna 406 may be oriented generally angularly upwardly and around theexterior surface 410 of the scanner 400. In this embodiment, the antenna406 may be fixedly secured by a suitable clamp 412 to a rotatable ring414 which, through support members, such as arms 420, 422 and 424, maybe fixedly secured to the undersurface of the scanner 400 such thatrotation of the ring 414 will effect rotation of the antenna 406 aboutthe scanner 400. A motor 430 may have an output shaft secured to pinion432 which may be engaged with annular rack 434. It will be appreciatedthat in this manner when a motor 430 is energized, the ring 414 willrotate in direction indicated by arrow B with respect to the scanner400, thereby establishing relative movement between the objectscontained within recess 402 and the antenna 406. This facilitatesobtaining the desired data with respect to the objects regardless of theorientation and depth of the objects within the recess 404.

While the embodiment of FIGS. 24 and 25 has an object-receiving recessof substantial depth and is particularly suitable for use as an exitscanner, this embodiment may also be employed as an entry scanner. Whenemployed as an entry scanner, a more shallow receptacle is preferablyemployed.

Referring to FIG. 26, there is shown a scanner having a housing 440which defines an upwardly open object-receiving recess 442. A generallyloop-shaped antenna 444 may have an end segment 446 within a strapelement 448 which has one portion 450 fixedly secured to outer surface452 of the scanner container 440 and another portion 454 secured toanother portion of the outer surface 452. The strap element 448 maydefine a loop wherein tubular section 446 is rotatably mounted. Theloop-shaped antenna 444 may be disposed exterritorialy of and spacedfrom the scanner housing 440. When the antenna 444 is rotated in amanner to be described hereinafter, end 460 of the antenna may movegenerally up and down, generally in the direction indicated by arrow C.A motor 464 has its output shaft 466 eccentrically mounted within cammember 468 such that energizing the motor 464 will cause rotation of theeccentric cam 468 in the direction of arrow D which will createresponsive reciprocating generally upward and downward movement ofsection 470 of the antenna as indicated generally by the double-headedarrow E. In this manner, relative movement between the antenna 444 andthe objects contained within recess 442 will be mechanically achieved.

Referring to FIG. 27, there is shown a scanner container 480 whichdefines an upwardly open object-receiving recess 482, a pair ofloop-shaped antennas 483 and 484 which are structured to be rotatedrespectively in the directions indicated by arrows F, G (section 502)responsive to motors 490 and 492 effecting rotation of their respectivecam elements 494 and 496 in the direction indicated respectively byarrows H and I. The antennas 483 and 484 are oriented to rotategenerally in planes perpendicular to each other. Antenna 483 may havesection 500 rotatably mounted to the exterior of wall 486, such as inthe manner in which antenna 444 is mounted in FIG. 26, for example, bystrap 485. Antenna 484 may similarly be rotatably secured to theexterior of wall 487.

Referring to FIGS. 28 and 29, three pairs of opposing antennas, eachhaving their own tuning circuits, are assembled into a generallycube-like configuration. The antennas which are shown in theillustrations may be square-shaped looped antennas. A first pair ofantennas 520, 530 may have, respectively, associated tuning circuits 522and 532. A second pair of antennas 534 and 544 may have, respectively,associated tuning circuits 536 and 546. A third pair of antennas 540 and550, respectively, may have associated tuning circuits 542 and 552.

In this embodiment of the invention, several methods of operation may beemployed. For example, a pair of antennas, such as 520 and 530, may bepowered, while the others are not powered, with a cycle of operationinvolving sequentially powering each of the three pairs of antennasduring a time when the other two pairs are not powered. In anotherembodiment, a pair of antennas powered and tuned, while the others arepowered and detuned. A similar cycle of operation may be employed. Eachpair of antennas sequentially may be powered in phase or out of phase inorder to direct the field, but it will generally be preferred to havethe powering occur in phase so as to create a higher concentration ofmagnetic flux in the space between the pair of antennas and to eliminateradiation outside thereof. These embodiments may be controlled by thecontrol circuitry (not shown in these views). In another embodiment, oneof each pair of opposing antennas may be unpowered or may or may nothave its tuning adjusted in concert with the opposing antenna of thepair.

Referring to FIG. 30, there is shown a single antenna having two opposedloops 600 and 602 connected by a bridge 604 and 606 and havingappropriate tuning circuitry 608, which is controlled by the controlcircuitry (not shown in this view). The antenna of FIG. 30 may beemployed as a substitute for a pair of opposed antennas, such as thoseshown in FIGS. 28 and 29. This antenna creates the same gate effect astwo opposing antennas powered and tuned simultaneously and in phase withone another. It will be appreciated that one or more of the antennas ofFIG. 30 may be combined with opposing pairs of antennas.

Referring to FIG. 31, there is shown a further modification of theinvention wherein a pair of closed-loop generally rectangular antennas620 and 626, each having their respective turning circuits 622 and 628,are oriented generally perpendicular with respect to each other. Thisantenna pair may also substitute for a pair of antennas of FIGS. 28 and29. The antenna pair of FIG. 31 may be powered and tuned simultaneouslyand be 180 .degree. out of phase with one another. This structurecreates a rotating field inside the boundary of the physical space. Thefield lines sweep 360 .degree. through the plane which is mutuallyperpendicular to the plane of each antenna 620 and 626. The embodimentof FIG. 31 replaces two pairs of opposing antennas or two double loopantennas. It is preferred to minimally employ a set of opposing antennasor one double loop antenna in conjunction with the antenna pair of FIG.31. The antennas 620 and 626 may be oriented such that their fields aredirected at an angle to the rotating field created by these antennas.

FIG. 32 shows a pair of antennas 650 and 656 having associatedrespective tuning circuits 652 and 658 positioned between a pair ofopposed loop antennas 660 and 664, each of which has its associatedtuning circuit 662 and 666. The field generated by antennas 660 and 664is at an angle to the rotating field created by antennas 650 and 656.

In the embodiment shown in FIG. 33, a double loop bridge antenna 670 iscombined with two antennas 690 and 694 with the bridge having a tuningcircuit 682. Antennas 690 and 694 have tuning circuits 692 and 696respectively. The bridge antenna 670 may generate a field at an angle tothe rotating field created by antennas 690 and 694.

In one embodiment, the apparatus may have one object detection zonecontaining antennas. The antennas may be used as either entry detectionzone antennas or exit detection zone antennas. For example, a switch maybe used to indicate to control circuitry 30 whether the antennas willfunction as entry detection zone antennas or as exit detection zoneantennas. The switch may be a mechanical switch, an infrared switch,proximity switch or any other suitable switch. An individual switch or acombination of switches may be used. Alternatively, control circuitry 30may be programmed to function as entry detection zone antennas or exitdetection zone antennas based on contextual cues.

It will be appreciated that a variety of materials, configurations andproperties may be employed in the antennas and identifiers of thepresent invention. With respect to the antennas, they may be made ofcopper or other materials having high conductivity.

An identifier on an object to be monitored may, in certain embodiments,be an RF tag or a microchip that utilizes any other suitable technologyto identify objects. Alternatively, an object may be equipped tospontaneously emit electromagnetic waves containing identificationinformation, which may be read by antennas. A bar code may also beattached to an object in order to identify it. An identifier of theinvention may be one that works through pattern recognition technology,whereby a visual image of the object is obtained, and control circuitryalgorithms are utilized to identify the object from its image. Those ofskill in the art will recognize that any of these or other suitableidentifiers or combination of identifiers may be used in the presentinvention.

With respect to identifiers, RF tags are one embodiment. Identifierssuch as RF tags may have various shapes and dimensions. The tags andassociated antennas may be operated in a range of frequencies. Whiletags are generally rigid, they may be made to be somewhat flexible. Anidentifier may be attached to an object by stitching the identifierbetween two layers of the object around the periphery on all four sidesto resist movement of the tag with respect to the object. In thealternative, they may be attached by alternate means such as suitableadhesives, such as by epoxies, resins and cyanoacrylates, for example.The tags may be passive and would therefore not function if not in adetection field tuned to their frequency.

RF tags used in the system may have information stored to specificmemory segments. For example, FIG. 41 shows an RF tag memory 700. RF tagmemory 700 may be programmed to store information identifying an object.For example, memory segment 700 may store information in memory segments702, 704, 706, 708, 710, 712, 714, 716 and 718. The information mayinclude the object's unique identifier (memory segment 702), the type ofobject (memory segment 704), the package identity (memory segment 706),the number of objects in a package (memory segment 708), the objectexpiration date (memory segment 710), the time the object was scanned in(memory segment 712), the time the object was scanned out (memorysegment 714), the time an antenna, such as the handheld antenna, scannedthe object (memory segment 716), and the identifying number of theantenna used to scan the object (memory segment 718). RF tag memory 700may store additional information such as whether the object has alreadybeen scanned in or scanned out, a flag indicating whether the object hasbeen scanned in or scanned out, the date of manufacture of the objectand any other desirable information.

Identifiers may be protected from deterioration and accidental orintentional data corruption. For example, identifiers may beprotectively encapsulated in inert biocompatible plastics. As theprotective plastic materials in which identifiers are encapsulated maybe water-impermeable, fluid-impermeable and gas-impermeable, theidentifiers can resist deterioration when exposed to gas sterilizationmethods. Identifiers may also be encapsulated in an outer material thathas electromagnetic shielding properties in order to prevent datacorruption due to the presence of other electromagnetic waves. Forexample, FIG. 42 shows package of objects in one embodiment of theinvention with a protective outer wrapping or covering, such as aprotective encapsulation. In FIG. 42, package 800 may have identifier802 which contains information identifying it. Package 800 may also havea protective encapsulation 804, which may be a protective plasticmaterial or a material with electromagnetic shielding properties.

Identifiers may also be protected from electromagnetic coupling withother identifiers, preventing a reduction in reading range. The effectsof electromagnetic coupling are generally greatest when identifiers arepacked in close proximity and are stacked center-on-center. In oneembodiment, electromagnetic coupling between identifiers may be reducedby positioning identifiers at strategic locations on objects. Theidentifier for each object may be positioned such that when each objectis packaged with another object, there will be maximum spacing betweentheir identifiers. For example, identifiers may be placed at alternatingcorners of objects so that there is maximum vertical spacing betweentags as shown in FIGS. 43 and 44. As shown in FIG. 43, the objects maybe packaged with all their identifiers facing the same verticaldirection. Alternatively, the objects may be packaged such that everyother object has their identifier facing in the same vertical direction,as shown in FIG. 44.

In another embodiment, identifiers may have protective covering in orderto minimize electromagnetic coupling. The protective covering may havecharacteristics and dimensions that helps to reduce electromagneticcoupling when placed between identifiers. For example, the protectivecovering may be a padded pocket which is thick enough so that, whenplaced between two tags stacked center-to-center, it separates the tagsand minimizes electromagnetic coupling. FIG. 45 shows an object 900 withan identifier 902. Object 900 may also have a protective covering 904 toreduce electromagnetic coupling. For example, absorbent material used inthe main body of object 900 may be thicker around identifier 902, asshown by the dotted line marking the perimeter of protective covering904.

In yet another embodiment, identifiers may be encapsulated to minimizeelectromagnetic coupling. The encapsulation used may be of differentshapes. For example, a disk-shaped encapsulation may be used as is shownin FIGS. 46a and 46b . As can be seen in FIG. 46a , the disk-shapedencapsulation 906 may be used to enclose identifier 908. The disk mayhave a plane parallel to that of the antennas in the system in order toaid detection of the identifier it encapsulates. The disk may also bechosen to be thick enough so that electromagnetic coupling is reduced toan acceptable degree when it is placed in between tags.

The disk may also be designed in order to further electromagneticcoupling. For example, the disk may have a “bump” at its center and maybe placed at the center of the identifier as shown in FIG. 47a . It canalso be seen from FIG. 47b that having a plurality of identifierscontained in disks with bumps at their centers may reduce thepossibility of center-on-center stacking between tags. This is because,as seen in FIG. 47b , disk-shaped encapsulations 806 and 808 areprevented from lying in a center-to-center position due to their bumps706 and 708. Other modifications and variations of this feature may beused.

The system provided by the present invention may be used alone or inconjunction with other systems. If the system is used alone as astand-alone device in a surgical field, it may be set up to communicatewith other stand-alone devices. This may facilitate the compilation ofinformation. Alternatively, a single stand-alone device may be adaptedto store information across multiple surgical fields and to combine thatinformation in a way that helps the user track the total number ofobjects in multiple surgical fields. For example, the user may be ableto determine the total number of a particular object utilized indifferent surgical fields. Control circuitry 30 may also be set up tocollect all the data on the objects detected by the individualstand-alone devices, and to compile the data in one database.

The methods and apparatus of the present invention may be used eitheralone, or in conjunction with other systems, methods and apparatus.Examples of systems, methods and apparatus that may be used inconjunction with the present invention are disclosed, e.g., in U.S.patent application Ser. No. 08/286,413, now U.S. Pat. No. 5,650,596,U.S. patent application Ser. No. 08/833,387, now U.S. Pat. No.5,923,001, U.S. patent application Ser. No. 10/411,885, now U.S. Pat.No. 6,998,541 and United States Patent Publication NumberUS2006/0044137, each of which is incorporated by reference in itsentirety.

It will be appreciated that the present invention provides a number ofefficient methods for effectively and accurately controlling themonitoring, detection, counting, identification and in some cases,further characterization of objects entering and exiting a surgicalfield or surgical site, so as to avoid inadvertent retention of anobject within a patient. In one embodiment, a patient is scanned as aresult of a lower array of antennas underlying the patient to determineif any objects are in a patient, particularly immediately prior toclosing of the patient at the end of the surgical procedure. A furtherrefinement of this embodiment involves the use of an overlying upperantenna or array of antennas which will more precisely define thedetection field at or adjacent the surgical site. In one embodiment, anobject entry detection zone and an object exit detection zone cooperateto monitor the use of surgical objects.

Whereas particular embodiments of the invention have been describedherein for purposes of illustration, it will be evident to those skilledin the art that numerous variations of the details may be made withoutdeparting from the invention as set forth in the appended claims.

The invention claimed is:
 1. A system for monitoring sponge usage duringa surgical procedure where a package comprising a plurality of surgicalsponges is provided, each of the plurality of surgical spongescomprising an RFID tag, each RFID tag storing unique RFID datarepresenting a one of the plurality of surgical sponges, the systemcomprising: a handheld scanner adapted for use in a plurality ofoperating modes in a surgical procedure, the scanner comprising anantenna capable of emitting a radio frequency detection field; andcontrol circuitry operable to control the handheld scanner andconfigured to: operate the handheld scanner in a first operating mode toscan in sponges to the surgical procedure; and operate the handheldscanner in a second operating mode to scan out sponges from the surgicalprocedure; the handheld scanner comprising a user control to selectivelytoggle the handheld scanner into the first operating mode andselectively toggle the handheld scanner into the second operating mode;wherein the control circuitry is configured to store count-in datarepresenting the one of the plurality of surgical sponges scanned in thefirst operating mode and count-out data representing the one of theplurality of surgical sponges scanned in the second operating mode. 2.The system of claim 1, wherein the control circuitry is configured tooperate the handheld scanner in a contextual operating mode wherein thecontrol circuitry is configured to automatically toggle the handheldscanner to operate in the first operating mode based on detecting theone of the plurality of surgical sponges at a first time and the controlcircuitry is configured to automatically toggle the handheld scanner tooperate in the second operating mode based on detecting the one of theplurality of sponges at a second time, the second time being after thefirst time.
 3. The system of claim 1, wherein the control circuitry isconfigured to compare the count-in data with the count-out data anddetermine the unique RFID data representing the one of the plurality ofsurgical sponges is present in the count-in data and is absent from thecount-out data, the control circuitry is configured to generate an alarmindicating that not all objects entering the surgical procedure haveexited the surgical procedure.
 4. The system of claim 3, wherein thealarm comprises one of an audible alert, a visual alert, andcombinations thereof.
 5. The system of claim 1, wherein the controlcircuitry is configured to compare the count-in data with the count-outdata and determine the unique RFID data representing the one of theplurality of surgical sponges is present in the count-out data and isabsent from the count-in data, the control circuitry is configured toadd the data from the count-out data to the count-in data.
 6. The systemof claim 1, comprising a display device in communication with thecontrol circuitry; and wherein the control circuitry is configured todisplay, on the display device, information selected from among thecount-in data, the count-out data, a comparison of the count-in datawith the count-out data, or combinations thereof.
 7. The system of claim1, wherein the control circuitry is configured to determine a packagequantity based on the unique RFID data of the one of the plurality ofsurgical sponges and store count-in data representing a number of theplurality of surgical sponges equal to the quantity.
 8. The system ofclaim 1, wherein the control circuitry is configured to compare a numberof surgical sponges of the package with a number of surgical spongesthat are supposed to be comprising the package; determine that thepackage is complete based on the number of surgical sponges of thepackage being equal to the number of sponges that are supposed tocomprise the package; and store count-in data representing the number ofsurgical sponges comprising the package entering the surgical procedure.9. The system of claim 8, wherein the control circuitry is configured todetermine the number of sponges that are supposed to comprise thepackage based on the unique RFID data representing the one of theplurality of surgical sponges.
 10. The system of claim 9, wherein theunique RFID data stores data representing the number of sponges that aresupposed to comprise the package as a quantity identifier.
 11. Thesystem of claim 8, wherein the control circuitry is configured toproduce an alert when the control circuitry determines the number ofsurgical sponges of the package is unequal to the number of sponges thatare supposed to comprise the package.
 12. The system of claim 1, whereinthe user control comprises a toggle switch.
 13. The system of claim 1,where the package is a first package, the plurality of surgical spongesis a first plurality of surgical sponges and where a second package isprovided, the second package comprising a second plurality of surgicalsponges; wherein the control circuitry is configured to store count-indata representing the first plurality of surgical sponges and the secondplurality of surgical sponges scanned simultaneously in the firstoperating mode.
 14. The system of claim 1, where the package is a firstpackage, the plurality of surgical sponges is a first plurality ofsurgical sponges and where a second package is provided, the secondpackage comprising a second plurality of surgical sponges; wherein thecontrol circuitry is configured to store count-out data representing thefirst plurality of surgical sponges and the second plurality of surgicalsponges scanned simultaneously in the second operating mode.
 15. Thesystem of claim 1, wherein the unique RFID data comprises a uniqueidentifier of a one of the plurality of surgical sponges, a packageidentifier unique to the package and common among the plurality ofsurgical sponges comprising the package, and a quantity identifier thatindicates a correct quantity of items that are supposed to comprise thepackage.
 16. A method for monitoring sponge usage during a surgicalprocedure using a monitoring system where a package comprising aplurality of surgical sponges is provided, each of the plurality ofsurgical sponges comprising an RFID tag, each RFID tag storing uniqueRFID data representing a one of the plurality of surgical sponges, themethod comprising: providing a handheld scanner adapted for use in aplurality of operating modes in a surgical procedure, the scannercomprising an antenna capable of emitting a radio frequency detectionfield, and control circuitry operable to control the handheld scanner;selectively operating the handheld scanner in a first operating mode toscan in sponges to the surgical procedure; selectively operating thehandheld scanner in a second operating mode to scan out sponges from thesurgical procedure; receiving a signal from a user control disposed onthe handheld scanner, the signal instructing the control circuitry toselectively operate the handheld scanner in the first operating mode orto selectively operate the handheld scanner in the second operatingmode; storing, with the control circuitry, count-in data representingthe plurality of surgical sponges entering the surgical procedure orcount-out data representing the plurality of surgical sponges exitingthe surgical procedure.
 17. The method of claim 16, comprising operatingthe handheld scanner wherein the control circuitry automatically togglesthe handheld scanner to operate in the first operating mode based ondetecting a first one of the plurality of surgical sponges at a firsttime, and automatically toggles the handheld scanner to operate in thesecond operating mode based on detecting the first one of the pluralityof surgical sponges at a second time, the second time being after thefirst time.
 18. The method of claim 16, comprising comparing, with thecontrol circuitry, the count-in data with the count-out data, anddetermining the unique RFID data representing a first one of theplurality of surgical sponges is present in the count-in data and isabsent from the count-out data; the method further comprisinggenerating, by the control circuitry, an alarm indicating that not allobjects entering the surgical procedure have exited the surgicalprocedure.
 19. The method of claim 18, wherein the alarm comprises oneof an audible alert, a visual alert, and combinations thereof.
 20. Themethod of claim 16, comprising comparing, with the control circuitry,the count-in data with the count-out data, and determining the uniqueRFID data representing a first one of the plurality of surgical spongesis present in the count-out data and is absent from the count-in data;the method further comprising adding, by the control circuitry, theunique RFID data representing the first one of the plurality of surgicalsponges from the count-out data to the count-in data.
 21. The method ofclaim 16, comprising displaying, by the control circuitry, on a displaydevice in communication with the control circuitry, information selectedfrom among the count-in data, the count-out data, a comparison of thecount-in data with the count-out data, or combinations thereof.
 22. Themethod of claim 16, comprising determining a package quantity based onthe unique RFID data representing a first one of the plurality ofsurgical sponges, and storing, by the control circuitry, count-in datarepresenting a number of the plurality of surgical sponges equal to thepackage quantity.
 23. The method of claim 16, comprising comparing anumber of surgical sponges of the package with a number of sponges thatare supposed to comprise the package; determining the package iscomplete based on the number of surgical sponges of the package beingequal to the number of surgical sponges that are supposed to comprisethe package; and storing count-in data representing the number ofsurgical sponges of the package entering the surgical procedure.
 24. Themethod of claim 23, comprising determining the number of sponges thatare supposed to comprise the package based on the unique RFID datarepresenting a first one of the plurality of surgical sponges.
 25. Themethod of claim 24, wherein the unique RFID data includes datarepresenting the number of sponges that are supposed to comprise thepackage as a quantity identifier.
 26. The method of claim 16, whereinthe user control comprises a toggle switch.
 27. The method of claim 16,where the package comprises a first package, where the plurality ofsurgical sponges is a first plurality of surgical sponges, and where asecond package is provided, the second package comprising a secondplurality of surgical sponges; and wherein storing, with the controlcircuitry, count-in data comprises storing count-in data representingthe first plurality of surgical sponges and count-in data representingthe second plurality of surgical sponges scanned simultaneously in thefirst operating mode.
 28. The method of claim 16, where the packagecomprises a first package, where the plurality of surgical sponges is afirst plurality of surgical sponges, and where a second package isprovided, the second package comprising a second plurality of surgicalsponges; and wherein storing, with the control circuitry, count-out datacomprises storing count-out data representing the first plurality ofsurgical sponges and count-in data representing the second plurality ofsurgical sponges scanned simultaneously in the second operating mode.29. The method of claim 16, wherein the unique RFID data comprises aunique identifier of a one of the plurality of surgical sponges, apackage identifier unique to the package and common among the pluralityof surgical sponges comprising the package, and a quantity identifierthat indicates a correct quantity of items that are supposed to comprisethe package.
 30. A system for monitoring sponge usage during a surgicalprocedure, the system comprising: a handheld scanner adapted for use ina plurality of operating modes in a surgical procedure, the scannercomprising an antenna capable of emitting a radio frequency detectionfield; and control circuitry in communication with the handheld scannerand configured to: operate the handheld scanner in a first operatingmode to scan in a sponge to the surgical procedure; and operate thehandheld scanner in a second operating mode to scan out the sponge fromthe surgical procedure; the handheld scanner comprising a user controlto selectively toggle the handheld scanner into the first operating modeand selectively toggle the handheld scanner into the second operatingmode; wherein the control circuitry is configured to store count-in datarepresenting the sponge scanned in the first operating mode andcount-out data representing the sponge scanned in the second operatingmode.